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morse vascular introducer set
North American Instrument
Summary: The Morse Vascular Introducer Set is a medical device used primarily by interventional radiologists and cardiologists for vascular access during procedures such as embolization. It is designed to facilitate the introduction of catheters and other devices into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K912961 ↗
Decision Date
September 11, 1991
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Morse Vascular Introducer Set was cleared through the FDA 510(k) pathway on September 11, 1991. Manufactured by North American Instrument, it is classified as a Class 2 device under product code DYB.
What It Is
The Morse Vascular Introducer Set is a medical device designed to provide vascular access. It consists of a sheath and dilator, allowing clinicians to introduce catheters and other instruments into the vascular system with minimal trauma. This device is particularly useful in procedures requiring precise and reliable vascular access, such as embolization or angiography.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings. It is essential in procedures like embolization, where precise catheter placement is critical. The introducer set is used in hospitals and specialized clinics, primarily for adult patients undergoing vascular interventions.
Indications for Use
The FDA-cleared indication for the Morse Vascular Introducer Set is to facilitate the introduction of devices into the vascular system. It is used in patients requiring vascular access for procedures such as embolization.
Practical Considerations
The Morse Vascular Introducer Set typically comes in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and devices, and clinicians should be familiar with the technique for safe insertion and removal to minimize complications.
Frequently Asked Questions
What is the Morse Vascular Introducer Set used for?
It is used for providing vascular access during procedures like embolization, allowing the introduction of catheters and other devices into the vascular system.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital and specialized clinic settings.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of devices into the vascular system, particularly in procedures requiring precise vascular access.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.